Evaluation of transcutaneous electrical nerve stimulation as an adjunct therapy in trigeminal neuralgia - a randomized double-blind placebo-controlled clinical study.

Suman Bisla, Ambika Gupta, Shalini Agarwal, Harneet Singh, Ankita Sehrawat, Aarti Singh
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Abstract

Background: Trigeminal neuralgia (TN) is a severe form of pain that affects the daily activities of a patient. Transcutaneous electrical nerve stimulation (TENS) therapy is an emerging option for the treatment of acute and chronic pain. The aim of this study was to evaluate the effect of TENS therapy as an adjunct to drug therapy for the treatment of TN.

Methods: A total of 52 patients diagnosed with TN according to the International Classification of Headache Disorders (version 3) were included. Each patient was randomized to either the TENS or placebo TENS groups. Intervention was given in continuous mode and 100-Hz frequency for 20 mins biweekly for 6 weeks. Parameters were measured at baseline, TENS completion and 3 months, 6 months, and 1 year of follow up. The parameters observed were mean carbamazepine dose, mean visual analog scale (VAS) score, mean present pain intensity (PPI) score, and functional outcome. Non-parametric analyses, one-way ANOVA and the Kruskal-Wallis test were applied for intragroup comparisons, while the Mann-Whitney U test and independent t-test were used for intergroup comparisons of variables. The chi-square test was applied to analyze categorical data.

Results: Compared to the placebo TENS group, the mean dose of carbamazepine in the TENS group was significantly reduced at TENS completion, as well as at 6 months and 1 year follow up. Changes in mean VAS score, mean PPI score, and functional outcome did not show significant differences between the groups (P>0.05).

Conclusion: TENS therapy does not lead to any changes in pain levels but it may reduce the mean dose of carbamazepine when used as an adjunct treatment in patients with TN.

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经皮神经电刺激作为三叉神经痛辅助疗法的评估--随机双盲安慰剂对照临床研究。
背景:三叉神经痛(TN三叉神经痛(TN)是一种严重影响患者日常活动的疼痛。经皮神经电刺激疗法(TENS)是治疗急性和慢性疼痛的新兴疗法。本研究旨在评估 TENS疗法作为药物疗法辅助治疗TN的效果:共纳入了 52 名根据国际头痛疾病分类(第 3 版)确诊为 TN 的患者。每位患者被随机分配到TENS组或安慰剂TENS组。干预采用连续模式,频率为 100 赫兹,每两周一次,每次 20 分钟,持续 6 周。在基线、TENS 结束、随访 3 个月、6 个月和 1 年时测量参数。观察参数包括平均卡马西平剂量、平均视觉模拟量表(VAS)评分、平均当前疼痛强度(PPI)评分和功能结果。组内比较采用非参数分析、单向方差分析和 Kruskal-Wallis 检验,组间比较采用 Mann-Whitney U 检验和独立 t 检验。采用卡方检验分析分类数据:与安慰剂 TENS 组相比,TENS 组的卡马西平平均剂量在 TENS 完成时、随访 6 个月和 1 年后均显著减少。各组间的平均 VAS 评分、平均 PPI 评分和功能结果的变化无明显差异(P>0.05):结论:TENS疗法不会导致疼痛程度发生任何变化,但在作为TN患者的辅助治疗时,可减少卡马西平的平均剂量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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